University of Virginia IRB for Health Sciences Research
Scientific Reviewer’s Review Checklist: Full Board
IRB-HSR#
Reviewer:
PI:
Meeting Date:
 If you find you are missing hard copies of things such as checklists or pages in protocol/consent
you may find them on the flash drive in your green bag!
SCIENTIFIC REVIEWER’S ORAL PRESENTATION
Please Note: This presentation should usually take about 5-7 minutes.
The scientific reviewer should state the following during their oral presentation to the IRB.
Planned responses need to also be written below.
1. PRESENTATION SUMMARY
A. What does the study involve in 2-3 sentences?
Include why the research is being done and briefly describe what will be done to subjects.
Comments:
B. Add your thoughts here about the potential usefulness of the protocol to present and future
patients in the targeted group. Do you feel the study is justifiable?
Comments:
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C. Does the study meet the criteria for IRB Approval per Federal Regulations?
(45CFR46.116/21CFR56.111)
Use “Points to Consider” starting on next page to assist in addressing the criteria below.
THESE POINTS MUST BE DISCUSSED DURING THE ORAL PRESENTATION AT THE IRB MEETING.
1. Risks to participants are minimized by using procedures which are consistent with
sound research design and do not unnecessarily expose participants to risk AND
whenever appropriate, that are already being performed for diagnostic or treatment
procedures.
2. Risks to participants are reasonable in relation to anticipated benefits to participants
directly or society in knowledge that may be expected to result.
Check One:
☐Potential benefit to subjects ☐No potential benefit to subjects ☐societal benefit
3. Selection of subjects is equitable, taking into account the purposes of the research,
the setting in which the research will be conducted, the special problems of
research involving vulnerable populations, the selection criteria and the recruitment
process.
4. Informed consent will be sought from each prospective subject or the subject’s
legally authorized representative, in accordance with, and to the extent required by
the regulations and the applicable elements of the consent form are included.
5. Informed consent will be appropriately documented per 45CFR46.117.
6. When appropriate, the research plan makes adequate provision for monitoring the
data collected to ensure the safety of participants.
7. When appropriate, there are adequate provisions to protect the privacy of
participants and to maintain the confidentiality of data AND when some or all of
the participants are likely to be vulnerable to coercion or undue influence, such as
children, prisoners, pregnant women, mentally disabled persons, or
economically or educationally disadvantaged persons, additional safeguards are
included in the study to protect the rights and welfare of these participants.
Comments:
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If any of the questions above are answered NO, the protocol cannot be approved.
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☐
Approval Criteria and “Points to Consider”
The criteria below should be used to review the protocol. Checking the boxes below is optional.
1. Risks to subjects are minimized (i) by using procedures which are
consistent with sound research design and do not unnecessarily expose
subjects to risk, and (ii)whenever appropriate, by using procedures
already being performed on the subjects for diagnostic or treatment
purposes. 45CFR46.111(a)(1)../..21CFR56.111(a)(1)
YES
NO
YES
NO
Points to Consider:
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Consider physical, psychological, social, legal and economic risks.
Can less risky procedures answer the question?
Can few procedures answer the question? Are the procedures needed at all?
Are the hypothesis and objectives clear?
Are there adequate preliminary data and is there appropriate justification for the
research?
Are there qualified staff and resources to conduct the research?
Are all services/specialties involved in the research represented in the personnel?
Can different exclusion criteria reduce risk?
Is there a plan in place to manage any potential conflict of interest?
Are procedures that will answer the scientific question being performed for nonresearch purposes?
o If so, can the data from these procedures be used to reduce the likelihood or
magnitude of harm?
Is there a clear differentiation between research and usual practice?
2. Risks to subjects are reasonable in relation to anticipated benefits, if any,
to subjects, and the importance of the knowledge that may reasonably be
expected to result. 45CFR46.111(a)(2)../..21CFR56.111(a)(2)
Points to Consider:
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Does the research have scientific merit?
Will the research achieve the proposed aims?
Does the investigator have access to a population that will allow recruitment of the necessary
number of subjects?
Are both risks and anticipated benefits accurately identified, described and evaluated?
Do the aims outweigh the risks and burdens to the subject?
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3.
Selection of subjects’ is equitable. 45CFR46.111(a)(3)../..21CFR56.111(a)(3)
YES
NO
YES
NO
Points to Consider:
Take into account the purposes of the research and the setting in which the research will be
conducted. Be particularly cognizant of the special problems of research involving vulnerable
populations
 Are burdens and benefits are distributed fairly? Will any group be unfairly burdened or
unfairly benefited?
 Does the nature of the research justify using the proposed subject population?
 Are the methods of recruitment appropriate?
 Is the amount of compensation and the proposed timing of disbursement present the potential
for undue influence?
 Are the inclusion and exclusion criteria are justified by science, are adequately defined and
equitable?
 If there is exclusion of women, minorities, and other vulnerable populations are they
justified?
 Is the setting, location and timing of recruitment appropriate for this study?
 Are recruitment methods well described and appropriate for this study?
4. Informed consent will be sought from each prospective subject or the
subject’s legally authorized representative.
45CFR46.111(a)(4)../..21CFR56.111(a)(4)
Points to Consider:
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Is the information given to the subject or the representative in a language that is
understandable to them? If not, have procedures been implemented? (e.g. use of translators,
use of consent in language, use of short forms)
Is adequate time devoted to the consent discussion and decision making process?
Do the circumstances of consent minimize the possibility of coercion or undue influence?
Have all issues regarding the capacity to make a decision been addressed appropriately?
Does the consent form include an exculpatory language through which the subject or the
representative is made to waive or appear to waive any of the subject’s legal rights?
Are steps taken to help the subjects or representatives understand the facts?
Does the investigator adequately address how he/she will determine that a subject
understands the research prior to providing consent/assent?
Are the appropriate persons being asked for consent/assent?
Are the timing, location and setting of obtaining consent acceptable?
Are payment arrangements acceptable?
Will parents and children be compensated and if so is the amount fair and distributed
appropriately between parent and child?
If study procedures are not complete or a subject withdraws is there any pro-rating of
compensation?
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NA
4a. The basic elements of the consent form per are included.
YES
NO
YES
NO
YES
NO
45CFR46.116(a)../..21CFR50.25(a)../..45CFR46.116(a)(5)../..21CFR50.25(a)(5)
Comments: IRB Templates and Administrative staff and confirmed all basic elements are
included.
(1)Research: purpose, duration, procedures
(2)Risks/ Discomforts
(3)Benefits
(4)Alternatives
(5)Confidentiality
(6)Compensation for Injury
(7)Whom to contact
(8)Right to refuse, or withdraw without penalty
Points to Consider:
Is the written consent form accurate, complete and consistent with the protocol?
4b. The additional elements of the consent form are included when
appropriate.
45CFR46.116(b)../..21CFR50.25(b)
Comments: IRB Templates and Administrative staff and confirmed all basic elements are
included.
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Unforeseeable Risks
Termination Language
Costs
Consequences of withdrawing
New Findings
The approximate number of subjects involved in the study
Compensation
5. Informed consent will be appropriately documented in accordance with
and to the extent required.
45CFR46.117(a)../..21CFR50.27(a)../.. 45CFR46.117(b)/..21CFR50.27(b)
Points to Consider:
• Will the participant or the participant’s legally authorized representative sign and date the
consent document?
• Will a copy of the consent document be given to the person signing the consent document?
 If documentation of consent will not be required, are all criteria met per
45CFR46.117/21CFR56.109
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6. When appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects.
YES
NO
YES
NO
45CFR46.111(a)(6)…/..21CFR56.111(a)(6)
Points to Consider:
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Does the protocol adequately specify:
o Who will monitor the data?
o What data will be monitored?
o How frequently will data be monitored?
o What analysis will be performed on the data?
o What decision rules (e.g., stopping rules) will be considered?
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Is there appropriate monitoring of the subject during and after the research (e.g.
safety tests, stopping rules, follow up visits etc.)?
Is there a plan to promptly detect unexpected harms or an increase in frequency or
severity of harms?
Is there an adequate plan to stop the protocol if benefits are proven to outweigh
harms or harms are proven to outweigh benefits?
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7. When appropriate, there are adequate provisions to protect the privacy of
subjects and to maintain the confidentiality of data.
45CFR46.111(a)(7)../..21CFR56.111(a)(7)
Points to Consider:
Privacy: having control over sharing ones self with others:
Issues include:
 How the potential subject is identified
 Where consent is negotiated
Confidentiality: data about subjects is not improperly divulged
Issues include:
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How data will be secured
Who will have access to data
When will data be discarded and how?
Are there adequate provisions to assure the privacy of the subject?
Does the investigator accurately disclose how their data will be protected?
Are confidentiality procedures being made to subjects? If so , are the protocol
procedures sufficient to meet their promises?
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7b. When some or all of the subjects are likely to be vulnerable to coercion or
undue influence, such as children, prisoners, pregnant women, mentally
disabled persons, or economically or educationally disadvantaged persons,
students, employees, paroles, terminally ill etc. additional safeguards
continue to be included in the study to protect the rights and welfare of these
subjects.
45CFR46.111(a)(7)(b) ../..21CFR56.111(a)(7)(b)
Points to Consider:
For all vulnerable populations included in this study ( may or may not
have a separate checklist noted above) consider the following:
o Is inclusion of the vulnerable population warranted?
o Is the research of importance to this vulnerable population?
o Can the research question be answered by using a nonvulnerable population?
o Are additional measures needed to protect these subjects in
terms of the recruitment process, payment, informed consent
process, where the research occurs, how information is managed
and protected and who conducts study procedures?
o Is consent monitoring required or the presence of a subject
advocate or witness during the consent procedure?
o IRB’s should not overprotect vulnerable populations so that they
are excluded from participating in beneficial research, or so that
important research information is never gathered in a way that
applies to them.
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YES
NO
NA
D. VULNERABLE POPULATIONS
Children: Also complete Vulnerable Populations Checklist : Minors
NA- no children to be enrolled
Children: Part A: Parental Permission (Check one)
One parent signature require
Two parents signature required
Children: Part B: Assent of Child (Check one)
Assent not required
Assent required (If checked, check below the type of assent documentation
to be used)
Verbal Assent
Written Assent
Use of Legally Authorized Representative (LAR):
Also complete the Vulnerable Populations Checklist: Cognitively Impaired
NA- no use of LAR requested
Not allowed if study involves more than a minor increase over minimal risk and the study has no
potential for therapeutic benefit to all subjects (e.g- not allowed if there is a placebo arm that involves
more than a minor increase over minimal risk).
(Check one)
Use of LAR approved
Use of LAR not approved
Prisoners: Also complete the Vulnerable Populations Checklist: Prisoners
NA- no prisoners to be enrolled.
Pregnant Women, Fetuses, Neonates:
Also complete the Vulnerable Populations Checklist: Pregnant Women, Fetuses, Neonates
NA- no pregnant women, fetuses, neonates to be enrolled.
Placenta after delivery, the dead fetus or fetal material
NA- no placenta after delivery, dead fetus or fetal material
IF YES, could any information associated with the material identify a living individual?
YES
NO If YES, a consent form must be signed by that living individual
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E.
Devices: SR vs NSR Determination
NA- no devices included in this study
The Food and Drug Administration (FDA) defines a device/ medical device as any instrument, apparatus, or other article that is used to prevent, diagnose, mitigate, or treat a disease or to
affect the structure or function of the body, with the exception of drugs. This means that the FDA classifies common hospital products such as catheters, thermometers, patient restraints
and syringes as medical devices.
Is the device being studied for safety and efficacy in this protocol?
IF YES, is the device exempt from IDE regulations?
YES
NO
YES
NO
Exemption Criteria
1. a legally marketed device when used in accordance with its labeling
2. a diagnostic device if it complies with the labeling requirements in §809.10(c) and if the testing:
a. is noninvasive;
b. does not require an invasive sampling procedure that presents significant risk;
c. does not by design or intention introduce energy into a subject; and
d. is not used as a diagnostic procedure without confirmation by another medically established
diagnostic product or procedure;
Additional guidance for an in vitro diagnostic device studies can be found in "Regulating In Vitro
Diagnostic Device (IVD) Studies." http://www.fda.gov/cdrh/comp/ivdreg.html
3. consumer preference testing, testing of a modification, or testing of a combination of devices if the
device(s) are legally marketed device(s) [that is, the devices have an approved PMA, cleared
Premarket Notification 510(k), or are exempt from 510(k)] AND if the testing is not for the purpose of
determining safety or effectiveness and does not put at risk;
4. a device intended solely for veterinary use;
5. a device shipped solely for research with laboratory animals and contains the labeling "CAUTION –
Device for investigational use in laboratory animals or other tests that do not involve human ."
6. a custom device
According to 21CFR812.2(c) (7) a custom device as defined in 812.3(b) is exempt unless the device is
being used to determine safety or effectiveness for commercial distribution. A custom device means a
device that:
(1) Necessarily deviates from devices generally available or from an applicable performance standard or
premarket approval requirement in order to comply with the order of an individual physician or dentist;
(2) Is not generally available to, or generally used by, other physicians or dentists;
(3) Is not generally available in finished form for purchase or for dispensing upon prescription;
(4) Is not offered for commercial distribution through labeling or advertising; and
(5) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be
made in a specific form for that patient, or is intended to meet the special needs of the physician or
dentist in the course of professional practice.
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If NOT exempt from IDE regulations: check one item below:
Significant Risk: if SR- requires IDE from FDA.
Non-significant Risk
Significant Risk Criteria
According to 21CFR812.3(m) a Significant Risk (SR) device study is one that presents a potential
for serious risk to the health, safety, or welfare of a subject and
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is intended as an implant; or
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is used in supporting or sustaining human life; or
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is for use of substantial importance in diagnosing, curing, mitigating or treating disease,
or otherwise prevents impairment of human health; or
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otherwise presents a potential for serious risk to the health, safety, or welfare of a subject*.
* Tips for determining if the device otherwise presents a potential for serious risk to the health,
safety or welfare of a subject
 If the participant must undergo a procedure as part of the investigational study, e.g., a
surgical procedure to implant the device, the IRB-HSR must consider the potential harm
that could be caused by the procedure in addition to the potential harm caused by the
device.
 Determine the Class of the device. If not sure see FDA Device Advice for additional help
in making this determination
o If the device is a Class I device it is generally NSR.
o If the device is a Class III device it is generally SR.
o If the device is a Class II device- the following additional information must be taken
into account:
 Evaluate the safety profile from previous use of the device: animal studies
or previous human use.
 Evaluate the safety profile of any similar device that might be on the market
 Evaluate the risk to the subject if the device fails or must be removed
 Review the SOM CTO recommendations or Contact the FDA for advice.
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F. Additional Considerations
 At the time of the continuation review, should the IRB have documentation from
anyone other than the PI to confirm no substantive changes have occurred that
would affect the safety of the subject and that the protocol has been conducted as
written?
If YES, check the applicable sources below:
YES
NO
YES
NO
YES
NO
Data Safety Monitoring Board/ Committee
Required if a board/ committee is in place per the protocol.
Post Approval Monitoring Audit
Other: Explain
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Does the research team have the resources necessary to protect subjects? (e.g.
time to conduct and complete , staff, facilities, subject population and
medical/psychosocial resources for subjects)?
If this is a multi-site study is the plan for communication of information among
the sites adequate to protect the subject?
G. Risk- Benefit Analysis
Do the anticipated benefits justify asking the subjects to undertake the risks?
H. Summary
Include summary of major risks and benefits and risk/benefit analysis.
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YES
NA
NO
G. List any required modifications:
INSTRUCTIONS:
1. The IRB may require the following examples as conditions of approval of research as a minor modification:
 Confirmation of specific assumptions or understandings on the part of the IRB regarding how the research will be
conducted (e.g., confirmation that the research excludes subjects who are cognitively impaired)
 Substantive changes to protocol or informed consent documents along with clearly stated parameters that the changes
must satisfy (e.g. subject will be withdrawn if their hematocrit is less than ( insert level- but must be above 25%).
 Requiring revision to protocol to include the type and amount of standard contrast material to be used and designating a
radiologist to review the protocol to ensure the use of the standard contrast material is medically appropriate.
 Rewriting the consent form into a lower lay language with review by the IRB chair to review the revisions to ensure the
risks are accurately described
2. The IRB may NOT require the following examples as conditions of approval of research as a minor modification:
 Clarify your plan to provide additional subject monitoring
 Provide a justification for the use of a placebo or enrolling children in the study
 Revise the hypothesis or study design.
 Provide a description of the procedures the control group will undergo
 Clarify if subjects who have taken aspirin within 14 days prior to enrollment will be excluded from the study
 Approval from other UVa review committees such as ISPRO, PRC etc. as their changes may affect the risk benefit
analysis.
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H. List any suggestions:
Suggestions are items that do not affect the risk/ benefit analysis and are not required- but may make the
protocol/ consent better.(e.g. spelling errors)
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Motion After the non-scientist has presented their review you will be called upon to state your motion.
Approve for one year
NOTE: Gene transfer studies may only be granted a 6 month approval.
Approve for period of less than 1 year
(Designate time frame: 3 months/ 6 months/after first 6 treated?)
NOTE: Gene transfer studies may only be granted a 6 month approval.
Approve for one year with suggestions
(e.g. typographical errors that do not affect the understanding of the study etc.)
Approved pending administrative verification
Verification that conditions have been met will be performed by IRB staff.
Check the item below requiring verification:
Completion of human subject research protection training by study team member
Receipt of signed protocol/application
Correction of grammatical or spelling errors as stipulated by IRB
Insertion of specific language as provided by IRB.
Receipt of IND/IDE # from FDA
Approved pending minor modifications and review by Chair or IRB member designee
PI will need to submit revised documents. Examples of items that require review by IRB chair
include asking for a section of the consent to be rewritten at a lower reading level to ensure
that risks are accurately described, etc.
Approved pending minor modifications and review by Scientific Reviewer or consultant, and
Chair or IRB member designee
PI will need to submit revised documents. Examples of items that require review by Scientific
Reviewer or Consultant include addition of risks of drug, addition of plan to inform subjects of
results to confirm plan is medically appropriate etc.
Withhold approval pending major modifications
PI will need to re-submit the protocol and consent at future IRB-HSR Meeting.
PI may be asked to attend future meeting to answer questions.
Examples of items which are considered major:
 the investigator has not answered all the questions in the protocol
 investigator has not provided adequate background information including previous
animal/ human data,
 procedures to be done are unclear- making it impossible to determine risk level.
Rejected
The investigator may attend a future IRB-HSR meeting to defend the protocol if he/she wishes
to pursue the study.
Tabled
Review of the protocol delayed to a future meeting until additional information may be
obtained. Protocol and consent forms do not need to be revised until after the next review.
Principal Investigator may be asked to attend future meeting or provide additional
information.
_____________________________________________
Signed (Scientific Reviewer)
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Date